a study of pain and quality of life outcomes in subjects with a single painful venous leg ulcer treated with apligraf®

Conditions: Venous Leg Ulcers

Summary: the objective of the study is to demonstrate that treatment with apligraf reduces venous leg ulcer (vlu)-related pain and improves the quality of life (qol) of patients with a painful vlu.


Eligibility criteria:
inclusion criteria: * subject is a minimum of 18 years of age. * subject has read, understood, and signed an institutional review board (irb)-approved informed consent form (icf). * subject is able and willing to follow study procedures and instructions. * subject reports moderate vlu-related pain (defined as ≥4 based on maximum pain level over preceding 24 hours) on numeric rating scale (nrs) at both week -2 and day 0). * subject has a partial or full-thickness vlu between 1-60 cm2 and 1-36 months duration, which, in the opinion of the investigator, has not adequately responded to conventional ulcer therapy. * female subject of childbearing potential has a documented negative urine pregnancy test. * subject (male or female) agrees to use highly effective methods of contraception for the duration of the study. exclusion criteria: * subject has more than 1 vlu. * female subject who is lactating. * subject with significant or severe non vlu-related chronic pain which, in the investigator's opinion, would impact subject's ability to evaluate their vlu-related pain. subject with non-vlu-related chronic pain must be on a stable pain medication regimen and must, in the investigator's opinion, not be anticipated to require a new pain medication for the chronic pain condition during the course of the study. * subject is not willing to discontinue the use of topical analgesics at the vlu (topical anesthetic is permitted for debridement). * subject who has arterial disease, as determined by an ankle-brachial index (abi), of \<0.65. * subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to study enrollment. * subject who is scheduled to have a vascular intervention on the study extremity during the study. * subject with a biopsy confirmed active malignancy at the vlu. also, subject with any active malignancy not at the vlu, with the exception of squamous cell carcinoma or basal cell carcinoma. * subject who is currently receiving, anticipates receiving, or has received, at any time within 30 days prior to screening visit, topical corticosteroids at the vlu. * subject has vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases. * subject has signs and symptoms of wound infection, cellulitis, or osteomyelitis at the vlu. * subject has a vlu with an avascular wound bed. * subject has a vlu with exposed bone, tendon, or fascia. * subject has other wounds (dfu, surgical, etc.) on the same limb as the vlu. * subject has a known hypersensitivity to bovine collagen or to the components of the apligraf agarose shipping medium. * subject previously treated with apligraf, or any other cell or tissue-based product at the vlu within 30 days of the screening visit. * subject who, in the opinion of the investigator, has a history of alcohol or substance abuse within the previous year that could interfere with study compliance (eg, inability to attend scheduled study visits). * subject, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.